Homocysteine levels and early heart relaxation changes in newly diagnosed high blood pressure
Relationship Between Elevated Homocysteine Levels and Early Diastolic Dysfunction in Newly Diagnosed Hypertensive Patients
See if higher blood homocysteine is linked to early diastolic (heart relaxation) problems in adults recently diagnosed with high blood pressure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Necmettin Erbakan University Academic / other |
| Locations | 1 site (Konya, Meram) |
| Trial ID | NCT07480265 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center observational cohort enrolling at least 500 adults diagnosed with essential hypertension within the previous six months. Participants undergo clinical evaluation, ambulatory blood pressure monitoring, ECG, laboratory testing including pooled plasma homocysteine measurement, and comprehensive transthoracic echocardiography with diastolic function and strain analysis when image quality permits. Participants are categorized by a homocysteine threshold of 15 µmol/L and groups are compared for diastolic dysfunction and left ventricular and atrial global longitudinal strain parameters. Clinical, laboratory, and echocardiographic data will also be used to develop a machine-learning model to help predict H-type hypertension.
Who should consider this trial
Good fit: Adults aged 18 or older with a new diagnosis of essential hypertension within the past six months who can complete clinic visits, ambulatory blood pressure monitoring, blood draws, ECG, and transthoracic echocardiography are ideal candidates.
Not a fit: Patients with resistant or secondary hypertension, known heart failure, atrial fibrillation/flutter, chronic kidney disease, current folate/B12/B6 supplementation, or inadequate echocardiographic image quality are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help identify people with new high blood pressure who already have subtle heart dysfunction so clinicians can monitor or treat them earlier.
How similar studies have performed: Prior studies have linked elevated homocysteine to vascular and myocardial injury, but few large prospective cohorts have specifically tested its association with early diastolic dysfunction in newly diagnosed hypertension, so the approach is partly supported but still relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older * Newly diagnosed essential hypertension within the previous 6 months * Ability and willingness to provide informed consent * Availability for clinical evaluation, laboratory testing, ambulatory blood pressure monitoring, electrocardiography, and transthoracic echocardiography Exclusion Criteria: * Resistant hypertension * Secondary hypertension * Acute coronary syndrome within the previous 6 months * Major surgery within the previous 6 months * Known heart failure * Pulmonary hypertension * Congenital heart disease * Atrial fibrillation or atrial flutter * Moderate or severe valvular heart disease * Chronic kidney disease * Anemia * Current folate, vitamin B12, or vitamin B6 supplementation or treatment * Inadequate echocardiographic image quality for strain analysis * Known systemic conditions that may significantly affect plasma homocysteine levels
Where this trial is running
Konya, Meram
- Necmettin Erbakan University Meram Faculty of Medicine — Konya, Meram, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: yunus emre yavuz, MD — Necmettin Erbakan University
- Study coordinator: yunus emre yavuz, MD
- Email: eyavuz@erbakan.edu.tr
- Phone: +90 5306069194
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.